Concerned By Confusion Over OTC Drug Brands, US FDA Offers Guidance On Developing Names
Executive Summary
Extending an OTC brand name to a product with a different active ingredient and indication creates a margin for error in the marketplace, FDA says. Recommendations include best practices to help minimize name-related medication errors and a framework FDA uses in evaluating proposed propriety names.
You may also be interested in...
US FDA Agrees With Only Comment On OTC Drug Naming Draft Guidance: More Time To Comment
FDA granted CHPA request for more time to comment on December draft guidance, “Developing Proprietary Names for Human Nonprescription Drugs.” CHPA said industry is conducting an ‘in-depth’ review of the principles of the draft.
How To Choose A Proprietary Rx Drug Name
US FDA final guidance describes possible study design to test whether selected names may misbrand a drug. Agency also okays use of two-letter USAN stems in product names and clarifies use of modifiers.
US FDA: User-Error Risks Grow When OTC Brands Extend With Different Ingredients, Indications
US FDA encourages firms to “identify and avoid potential problems before the product is marketed” by comparing proposed names against the agency’s best practices recommendations and seeking the agency’s input.